CHICAGO--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), the Breast International Group (BIG), Breast European Adjuvant Study Team (BrEAST) and Frontier Science Foundation (FS) today announced the Phase III APHINITY study showed adjuvant (after surgery) treatment with the combination of Perjeta® (pertuzumab), Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen) significantly reduced the risk of breast cancer recurrence or death (invasive disease-free survival; iDFS) by 19 percent in people with HER2-positive early breast cancer (EBC) compared to Herceptin and chemotherapy alone (HR=0.81; 95% CI 0.66-1.00, p=0.045). At three years, 94.1 percent of people treated with the Perjeta-based regimen did not have their breast cancer return compared to 93.2 percent treated with Herceptin and chemotherapy. The safety profile of the Perjeta-based regimen was consistent with that seen in previous studies, with a low incidence of cardiac events and no new safety signals.
Based on data available at the time of the primary analysis, an estimate of iDFS at four years showed that 92.3 percent of people treated with the Perjeta-based regimen did not have their breast cancer return compared to 90.6 percent treated with Herceptin and chemotherapy, suggesting that further analyses with longer follow-up will be important to provide additional insights on these treatments.
“The goal of adjuvant treatment is to help each person with cancer have the best chance of a cure, and we come closer to this goal with each advance,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “In the APHINITY study, the Perjeta-based regimen improved upon the high bar set by Herceptin in people with HER2-positive early breast cancer. We look forward to working with global health authorities to bring this treatment option to patients.”
